We wrote previously about the safety profile of Linzess in this August 2014 article, “July 2014 Boxed Warning For Linzess: Irritable Bowel Syndrome / Constipation Drug May Be Unsafe And Cause Diarrhea In Children”.
On the morning of April 28, 2016 we found this Phase Five Research analyst report about Linzess posted online: “Uncovered: fatal safety issues linked with Ironwood’s drug, Linzess”.
From the first part that Phase Five Research April 26, 2016 document:
Executive summary[Ironwood (IRWD)’s] constipation drug, Linzess, is causing severe and fatal adverse events – Our research has uncovered Linzess (linaclotide) to be the primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities and 10 cases of adverse events which required intervention, all in just 3 years since its launch in 2013. Backed by FDA case files, we believe that the findings outlined in this report will lead to the removal of Linzess from the market. We have been in discussion with the FDA’s Division of Gastroenterology and Inborn Errors Products representatives and shared our findings with them.
By the afternoon of April 28, however, this 65-page PDF document was no longer available at the URL where it had been earlier in the day. Instead, there was only a blank single page.
Starting the next day, April 29, and still today, May 2, one now sees this short notification set forth on that single page:
The Phase Five report on Ironwood Pharmaceuticals Inc is
temporarily unavailable due to an issue that does not affect the
validity of the findings or our conclusions, which we firmly
We are working on making the report available again soon.
Be assured that we will be watching for more developments concerning this April 26, 2016 Phase Five Research analyst report about Linzess. And if you happen to know or learn anything about the circumstances of this rather mysterious analyst report, please share it with us by posting a Comment on the full version of this article over on our Drug Injury Watch blog.[Read this article in full at original source]
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